Feasibility of Frontal Cerebral Hypothermia as a Treatment for Insomnia

描述（由申请人提供）：流行病学研究中报告的失眠患病率范围为美国人口的10-40%（3000万至1.2亿人），全球报告的患病率相似。催眠药是治疗失眠的主要药物，每年产生约50亿美元的收入，但严重的不良事件限制了它们的使用。失眠的行为治疗是有效的，但所涉及的专门培训和技术只适用于一小部分失眠患者。因此，对于安全、有效、非侵入性、理想的非药物治疗失眠存在巨大的市场需求。区域性脑热疗法（RCTT），旨在扭转失眠患者中枢神经系统过度觉醒的干预措施，提出了满足这一需求。Eric A. Nofzinger，医学博士，Cerjve Inc.总裁兼首席执行官，匹兹堡大学精神病学教授和睡眠神经成像研究项目主任发明了一种新型的医疗设备来提供RCTT。Cerjve公司Nofzinger是匹兹堡大学的一家分拆公司，由Nofzinger博士创立，负责许可，开发和商业化这项技术。本STTR提案代表Cerjve Inc.的研究组成部分。在小型临床试验中测试该设备的可行性。该提案将在医学博士丹尼尔J. Buysse的指导下利用世界级睡眠中心的资源。以及Cerjve Inc.的数据管理、统计和智力资源，包括其创始人兼首席执行官诺夫辛格博士该设备本身包括一个覆盖大脑前额皮质上方头皮的热垫、一个温度控制浴槽和一个带有塑料管的泵，用于将热流体从浴槽循环到热垫。它代表了第一种使用RCTT技术治疗失眠的非侵入性医疗器械。该STTR项目的长期目标是确定该医疗器械治疗失眠症的可行性。本I期提案的目的是提供可行性数据，以开始解决RCTT治疗失眠有效且耐受性良好的假设。10名失眠症患者将接受3种不同温度设置的器械治疗和无器械对照。为了控制适应效应，治疗顺序将在受试者中随机分配。如果在本I期提案中发现提示性效应，则将提出一项更大规模的II期研究，以使用该器械进行更大规模的确证性临床试验。为Cerjve开发的财务预测表明，该公司将面临巨大的商业机会，这主要是由该设备有望占据的市场空间驱动的。公共卫生相关性：在流行病学研究中报道的失眠的患病率和相关的发病率在美国人口的10-40%之间。现有的治疗方法有显著的不良事件或不广泛使用。如本STTR I期申请中提出的，用于治疗失眠症的安全、有效医疗器械的可用性预计将对公共卫生产生重大影响。

DESCRIPTION (provided by applicant): The prevalence of insomnia reported in epidemiologic studies ranges from 10-40% of the population in the United States (30 to 120 million people) with similar rates reported worldwide. Hypnotics are the primary medical treatment for insomnia, generating revenues of about $5 billion/year, yet significant adverse events limit their use. Behavioral treatments for insomnia are efficacious, but the specialized training and techniques involved are available to only a minute fraction of insomnia sufferers. Therefore, a large market need exists for a safe, effective, non-invasive, desirable, non-pharmaceutical treatment for insomnia. Regional cerebral thermal therapy (RCTT), an intervention designed to reverse the hyperarousal in the central nervous system found in insomnia patients, is proposed to meet this need. Eric A. Nofzinger, M.D., President and CEO, Cerjve Inc., Professor of Psychiatry and Director of the Sleep Neuroimaging Research Program at the University of Pittsburgh, has invented a novel medical device to deliver RCTT. Cerjve Inc. is a University of Pittsburgh spin off company, founded by Dr. Nofzinger, to license, develop and commercialize this technology. This STTR proposal represents a research component of Cerjve Inc. to test the feasibility of the device in a small clinical trial. The proposal will utilize the resources of a world-class sleep center under the direction of Daniel J. Buysse, M.D. at the University of Pittsburgh as well as the data management, statistical, and intellectual resources of Cerjve Inc., including its founder and CEO, Dr. Nofzinger. The device itself consists of a thermal pad that covers the scalp over the prefrontal cortex of the brain, a temperature controlling bath, and a pump with plastic tubing for circulating the thermal fluids from the bath to the thermal pad. It represents a first in kind, non-invasive, medical device that uses the RCTT technology for the treatment of insomnia. The long-term goal of this STTR Project is to determine the feasibility of this medical device in the treatment of insomnia. The aims for this Phase I proposal are to provide feasibility data to begin to address the hypothesis that RCTT is effective and well tolerated in the treatment of insomnia. Ten insomnia patients will receive treatment with 3 different temperature settings of the device and a no device control. To control for adaptation effects, the order of treatments will be randomized across subjects. If suggestive effects are noted in this Phase I proposal, a larger Phase II study will be proposed to conduct a larger confirmatory clinical trial using the device. Financial projections developed for Cerjve suggest a large commercial opportunity for the company primarily driven by the market space this device would be expected to capture. PUBLIC HEALTH RELEVANCE: The prevalence of insomnia, with associated morbidity, that is reported in epidemiologic studies ranges from 10-40% of the United States population. Available treatments have significant adverse events or are not widely available. The availability of a safe, effective medical device for the treatment of insomnia such as that proposed in this Phase I STTR application would be expected to have a significant public health impact.